510(k) · Cleared
ClearedQDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Versant Medical Physics and Radiation Safety · IYX Camera, Scintillation (Gamma)
Cleared on Aug 28, 2023 as substantially equivalent to K163687 (Hermes Medical Solutions AB, 2017) after a 214-day review. Its family tree reaches back 2 generations to 2004.
- Decided
- Aug 28, 2023
- Review
- 214 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033960 (2004). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYX device
- #1 K212587 3D-RD-Sscore 5.2 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K163687 | Olinda ExmSummary page 5…edical Physics and Radiation Safety, Kalamazoo, Michigan) claims substantial equivalence through the 510(k) premarket notification process [21 CFR 807.92(a)(3)]: K163687 OLINDA/EXM v. 2.0 Hermes Medical Solutions AB Regulation Number 21 CFR 892.1100 Regulation Name: Scintillation (Gam… | 2017 |
| † | K191216 | Voxel Dosimetry™ v1.0 | 2019 |
| † | K182966 | PLANET Onco Dose | 2019 |
| † | K182624 | MIM - MRT Dosimetry | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K163687.
How does its category compare?
All IYX devicesIYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · IYX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · IYX
82in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYX
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYX
1in 2022
MAUDE reports naming product code IYX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 8 |
| 2010 | 4 | 82 | 0 | 5 |
| 2011 | 3 | 82 | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
QDOSE® Multi-purpose Voxel Dosimetry is indicated for use to provide estimates of radiation absorbed dose to organs and tissues of the body from medically administered radiopharmaceuticals, and to calculate total-body effective dose. Radiation absorbed dose calculations are based on clinical measurements of radioactivity biodistributions and biokinetics. QDOSE® is intended for applications in clinical nuclear medicine, molecular radiotherapy, radiation…
Read the full statement (111 words)
QDOSE® Multi-purpose Voxel Dosimetry is indicated for use to provide estimates of radiation absorbed dose to organs and tissues of the body from medically administered radiopharmaceuticals, and to calculate total-body effective dose. Radiation absorbed dose calculations are based on clinical measurements of radioactivity biodistributions and biokinetics. QDOSE® is intended for applications in clinical nuclear medicine, molecular radiotherapy, radiation safety evaluations, risk assessment, record-keeping, and regulatory compliance. QDOSE® is indicated for use by professionals (medical physicists, radiologists and oncologists including nuclear medicine physicians), radiologic imaging technologists, health physicists and radiation safety officers and administrators, students in training, and others having interest in ability to calculate internal radiation doses from medically administered radiopharmaceuticals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230221: QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230221
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026